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Medical devices play a key role in the diagnosis and treatment of many conditions and life saving treatments. To insure patient safety, the effectiveness of such medical devices should be carefully evaluated. Package integrity testing of medical devices is a crucial part of the manufacturing process.

Medical device package testing methods offered by PTI

PTI’s Airborne Ultrasound technology (ABUS) is a seal quality inspection test method, capable of non-destructively examining packaging seal quality for defects, primarily flexible packaging seals. Under this method, ultrasound waves are passed through the pouch seal, creating a reflection of sound waves. The signal strength variations are analyzed to identify the presence of seal defects. Airborne Ultrasound technology creates a quick analysis of the seal area without tampering with the packaging to identify many common seal defects, such as incomplete or missing seals, wrinkles, and channel defects. The technology is in high demand due to its applicability across several industries, specifically the medical device industry. “Ultrasound is the only technology capable of identifying what the quality of that physical bonded nature of the seal materials are,” comments Tyler Harris, applications engineer at PTI- Packaging Technologies & Inspection. Medical device packaging including TYVEK® pouches is a very common application for ABUS technology.

PTI's Seal Scan (Offline) and Seal-Sensor (Inline) technology have further redefined pouch seal integrity testing. Both these technologies utilize non-contact airborne ultrasonic testing technology. With these advancements, Airborne Ultrasound technology has positioned itself to be the most sensitive method for non-destructive seal quality testing, in both the laboratory and in automated 100% inline testing production lines. ABUS is an ASTM Test Method F3004, recognized by the FDA as a standard for seal quality inspection and also referenced in the USP 1207 chapter guidelines.

For several decades, Vacuum Decay has been proven to be the most practical and sensitive leak detection method for medical device and pharmaceutical packaging. It is a Container Closure Integrity Test (CCIT) capable of evaluating a wide range of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. Vacuum Decay, being a non-destructive test method, does not cause any damage to the package being tested. This reduces significant waste and allows operators to have a thorough understanding of package integrity and package quality.

PTI’s VeriPac inspection technique is an ASTM approved (F2338), FDA recognized testing method capable of evaluating a wide range of high-risk package applications. To conduct this test, packages are first placed in a well-fitted evacuation test chamber, which has an internal or external vacuum source. The test operator continuously monitors the vacuum levels to identify variations from a pre-determined targeted vacuum level. In the presence of a defect, air escapes from the package into the test chamber. Packages without any defect retain the air, maintaining a constant chamber vacuum level. It is an ideal solution for medical device manufacturers to assure that the product meets regulatory standards. Based on the packaging materials used and the level of test sensitivity required, manufacturers can select the appropriate VeriPac model.

Package validations for medical devices play a significant role in ensuring safe and effective use of products when they reach the patient. Packaging for these safety-critical products must withstand the rigors of the manufacturing process, storage, and the distribution cycle. Package integrity is crucial to maintaining sterility for medical devices, especially those that are to be used during medical procedures or implanted into patients. This is because even a minute defect in the package can affect sterility of the device and cause health risk to the patient. Given below is a list of non-destructive package inspection techniques that help maintain highest quality standards.

CCI techniques offered by PTI

Vacuum Decay technology

Vacuum Decay is a non-destructive package inspection technique that offers the ability to inspect both the entire body of the package and seals for micro leaks and defects. The technology proven to provide reliable, reproducible, repeatable, and accurate quantitative results, is recognized by the FDA as a consensus standard for container closure integrity testing (CCIT). Vacuum Decay leak test method is an ASTM Test method (ASTM F2338) that was developed using PTI instruments, it is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207).

Technology overview

Vacuum Decay test method is simple in practice and challenges container integrity based on fundamental physical properties. The samples are placed in a closely fitting test chamber, equipped with external vacuum source. A pre-determined vacuum level is selected depending on test sample and level of sensitivity required. The next step involves evacuating the test chamber and test system dead space for a pre-determined period. Differential pressure transducers are used to monitor change in vacuum level for a specified period. A pressure increase beyond predetermined pass/fail limit indicates container leakage.

Advantages of Vacuum Decay technology:

• Non-destructive package inspection system
• Accurate and reliable results
• Definite pass/fail result based on quantitative test data 
• Accommodates multiple packaging formats
• Eliminates destructive, subjective testing methods 
• Effective in detecting even minute leaks 

Airborne Ultrasound technology

Airborne Ultrasound technology is a non-destructive Container Closure Integrity test used to examine seal quality for defects. It is an ASTM Test Method F3004 and FDA recognized standard for seal quality integrity testing. These tests are primarily conducted to provide advanced seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology is a non-destructive and non-invasive seal quality inspection technique suitable for many materials including Tyvek, paper, foil, film, aluminum and plastic. Airborne Ultrasound technology offers a comprehensive approach to evaluate seal quality even in conditions where a seal has a defect but may not leak.

Technology overview

Under this method, ultrasonic waves are propagated through the package seals as they move along the sensor head. This causes reflections of sound waves. The signal strength is either eliminated or reduced in the presence of any defect/leak. Such variations in signal strength are closely monitored to identify the defects.

Benefits of Airborne Ultrasound technology

• Non-destructive, non-subjective, no sample preparation
• Accurate and reliable results
• Deterministic package inspection technique 
• Works on multiple packaging formats and materials 
• Economical cost-effective solution for seal integrity testing
• Can be applied to 100% inline seal quality testing